Colorado State University Biosafety Office: (970)-491-8268 or (970)-567-6607
Effective Date: May 11, 2017

PURPOSE OF THIS POLICY

Colorado State University, the Office of the Vice President for Research, and the Biosafety Office are
committed to ensuring that all biological research and instructional activities conducted at Colorado
State University (CSU) are conducted safely and according to the current international, national, and
CSU regulations, guidelines, and policies.

INTRODUCTION

As stated in international, national, and CSU documents (see References and Supplemental
Information), it is imperative that all CSU laboratories conducting research with infectious or potentially
infectious material, including recombinant or synthetic nucleic acids, be audited periodically for
compliance with regulations and best practices.

APPLICATION OF THE POLICY

This Biosafety Audit Policy applies to any research laboratory involving recombinant or synthetic nucleic
acids, and/or infectious or potentially infectious material conducted at BSL-1 or BSL-2 containment.

BIOSAFETY LABORATORY AUDIT CYCLES

• BSL-1 Laboratories
  • Year 1 of the Biosafety audit cycle (New PI or the first time the PI needs an audit), the
    Biosafety Office will conduct biosafety audits jointly with each Principal Investigator
    and/or the PI delegate.
  • Subsequent years the PI and/or PI Delegate will be notified when they need to complete
    the Biosafety Self Audit, and the PI and/or PI delegate will conduct self-audits annually,
    using the Biosafety audit form.
  • The completed Biosafety Self Audits will be submitted to the Biosafety Office.
• BSL-2 Laboratories are conducted on a three-year cycle
  • Year 1 of the Biosafety audit cycle (New PI or the first time the PI needs an audit), the
    Biosafety Office will conduct biosafety audits jointly with each Principal Investigator
    and/or the PI delegate.
  • Years 2 and 3 of the Biosafety audit cycle, the PI and/or PI delegate will conduct self-audits annually, using the Biosafety audit form.
  • The completed Biosafety Self Audits will be submitted to the Biosafety Office.
  • This cycle repeats every 3 years.

RESPONSIBILITY

1. The laboratory audit is a vested partnership between the Biosafety Office, the IBC, and the
   Office of the Vice President for Research with the CSU research community. The ultimate goal is
   to ensure that our CSU research employees, others in the greater Fort Collins community, and our environment are not endangered by our research.
2. For the audit conducted by BSO (or when requested by the BSO or IBC), it is the responsibility of
   the PI and/or the PI’s delegate to schedule a biosafety audit within the designated time period
   requested.
   1. The completed audit, with recommendations and action items, will be filed in the
      Biosafety Office and a copy will be returned to the PI.
   2. It is the responsibility of the PI to ensure that the action items are addressed within the
      designated time period, or to contact Biosafety to request additional time, if needed.
3. For Year 2 and 3audits, it is the responsibility of the PI to conduct self-audits and to file the
   completed self-audit with the Biosafety Office. The audit forms will be provided to the PI and/or
   the PI’s delegate prior to the time the audit is due.
4. Audits by the Biosafety Office may be performed more often at the request of the PI and/or the
   PI’s delegate, at the request of the IBC, after a significant incident, when research programs
   undergo significant changes or when necessary for other reasons (e.g., preparing for federal
   agency inspections).

REFERENCES AND SUPPLEMENTAL INFORMATION

1. Statement from the World Health Organization:
   

   “…it is the technical and moral duty of laboratory managers and laboratory workers … to reassure the general public …and to prove that the biorisks inherent to laboratory work are controlled withappropriate safeguards to meet their expectations.”

   WHO, 2006, Biorisk Management: Laboratory Biosecurity Guidance, 1st ed., Geneva

2. BMBL 5
   • p. 15 and 16 Potential Hazards Associated with Work Practices, Safety Equipment, and Facility Safeguards
     – Safety equipment such as biological safety cabinets (BSC), centrifuge safety cups, and sealed rotors are used to provide a high degree of protection for the laboratory worker from exposure to microbial aerosols and droplets. Safety equipment that is not working properly is hazardous, especially when the user is unaware of the malfunction. Poor location, room air currents, decreased airflow, leaking filters, raised sashes, crowded work surfaces, and poor user technique compromise the containment capability of a BSC. The safety characteristics of modern centrifuges are only effective if the equipment is operated properly. Training in the correct use of equipment, proper procedure, routine inspections and potential malfunctions, and periodic re-certification of equipment, as needed, is essential.
   • p. 112 Security Updates and Re-evaluations – The biosecurity risk assessment and program should be reviewed and updated routinely and following any biosecurity-related incident. Reevaluation is a necessary and ongoing process in the dynamic environments of today’s biomedical and research laboratories. Biosecurity program managers should develop and conduct biosecurity program audits and implement corrective actions as needed. Audit results and corrective actions should be documented. The appropriate program officials should maintain records.
3. NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH
   Guidelines); April 2016 Section I-D.

   Compliance with the NIH Guidelines“As a condition for NIH funding of recombinant or synthetic nucleic acid molecule research, institutions shall ensure that such research conducted at or sponsored by the institution, irrespective of the source of funding, shall comply with the NIH Guidelines.”

4. Arthropod Containment Guidelines
   • p.16: In the arthropod vector laboratory, this must be combined with regular monitoring for escaped arthropods, e.g., through direct counting of infected arthropods, an effective arthropod trapping program, and regular inspection of the facilities for disrepair that could result in escape.Risk assessment must also include an evaluation of the experience and skill level of at risk personnel such as laboratorians, maintenance, housekeeping, and animal care personnel. Additional education may be necessary to ensure the safety of persons working at each biosafety level.”
   •  p. 31: Facility Compliance Monitoring. The facility is evaluated annually for compliance with the ACL-2 level. The principal investigator or insectary director inspects the facility annually to ensure that alterations and maintenance have not compromised the containment characteristics. Adequacy of the practices and facility in view of changes in research protocols, agents, or arthropods are considered.
5. The CSU Biosafety Policy
6. Colorado State University Biosafety Manuel 2016, Section 3 (3.a. and 3.b.)